Sterile sheath apparatus for fiber optic illuminator with compatible lens

ABSTRACT

A sterile sheath for enclosing certain surgical illuminating lamp structures having elongated light-transmitting shafts with a light-transmitting lens means disposed at the tip end of the light-transmitting shaft. The sheath means of the present invention comprises an elongated tubular sheath having a closed end with a lens element secured to and forming a portion of the closed end, and with an opening at the other end thereof, the tubular sheath having sufficient length to cover that portion of the light-transmitting shaft having a sterile requirement. The light-transmitting lens element at the tip end is adapted to be disposed in series with a lens arranged on the light-transmitting shaft. The sheath has a pair of generally axially extending slots formed adjacent the open end to form a pair of grasping ears, with one of the axially extending slots having a length in substantial excess of the other in order to provide the grasping ears with substantial asymmetry.

sen-ewes 511% r 1112 31120911172 SEARCH ROOM United Statto 1 uncut l 13,809,072 Er ek e a1, SUBSTITUTE FOR MISSING XR 45 May 7 STERILE SHEATHAPPARATUS FOR FIBER OPTIC ILLUMINATOR WITH Primary Examiner-Charining'L.Pace COMPATIBLE LENS [75] Inventors: Robert A. Ersek; Donald E. Wall;[57] ABSTRACT Michael C. Garity, all of Minneapolis Minn. A sterilesheath for enclosing certain surgical lllllmlnati'ng lamp structureshaving elongated lightl Assigneei Med General Minneapolis, transmittingshafts with a light-transmitting lens means Mimh disposed at the tip endof the light-transmitting shaft. The sheath means of the presentinvention comprises [22] Flled' 1971 an elongated tubular sheath havinga closed end with I PP 1871297 1 :1 lens element secured to and forminga portion of the closed end, and with an opening at the other end 52 us.c|.....' 128/23, 128/397 were, the W sheath having Sufficient length 511111. c1. A61b 1/06, A6ln 5/06 9 that. of the "ght'trfmsmlttmg .Shaft[58] Field of Search; 128/6 16 23 397 398 mg a sterlle requirement. Thelight-transmitting lens element at the tip end is adapted to be disposedin se- [56] References Cited 7 ries with a lens arranged on thelight-transmitting shaft. The sheath has a pair of generally axiallyextending slots formed adjacent the open end to form a pair of graspingears, with one of the axially extending slots having a length insubstantial excess of the other in order to provide the grasping earswith substantial UNITED STATES PATENTS 2,768,736 10/1956 Govoni 206/1652,987,960 6/l96l Sheldon 3,l32,646 5/1964 Hett 3,426,749 2/1969 Jephcott128/11 asymmetry. FOREIGN PATENTS OR APPLICATIONS I o 885,770 8/1953Germany ..l28/6 7 Clam, 4 Draw F'gures PATENTEDIAY new INVENTORS X 7 2Ev 4 5 Arrozmzy STERILE SHEATH APPARATUSFOR FIBER OPTIC ILLUMINATOR WITHCOMPATIBLE LENS CROSS-REFERENCES'TO RELATED APPLICATIONS The presentinvention constitutes a structure suited for use in connection withsurgical illuminating apparatus of the type disclosed in my co-pendingapplication Ser. No. 65,222, filed Aug. I9, 1970, entitled FIBER OPTICFOR SURGICAL LAMP, and assigned to the same assignee as the presentinvention. The present invention is also related to that certaininvention disclosed and claimed in my co-pending application Ser. No.187,295 entitled STERILE SHEATI-I FOR SUR- GICAL ILLUMINATOR, executedon even date herewith, and assigned to the same assignee as the presentinvention.

BACKGROUND OF THE INVENTION 1. Field of the Invention The presentinvention relates generally to protective sheath apparatus for surgicalilluminating equipment, and more particularly to such sheaths which haveintegral lens closure elements and which may be used in covering certainportions of surgical illuminating devices in order to provide a sterileenvelope for the illuminating device and its environment. Morespecifically, the invention relates to such protective sheaths which maybe utilized in combination with a surgical illuminator apparatusutilizing a bundle of fiber optics to transmit light from a source to aremote lens, with the sheath apparatus being utilized to cover theportion of the fiber optic bundle which is required to be sterile andhaving a lens element forming the closure for the bundle. The sheathapparatus has a light-transmitting lens element secured to one endthereof to form a closed tip end. This lens element is securely fastenedto the end of the tubular body portion of the sheath so as to avoid azone which could attract contacting fluids thereto by capillarity. v

2. Description of the Prior Art Pursuant to present established medicalprocedures,

' it is normally required that all devices utilized in surgery besterilized by either steam autoclaving, gas autoclaving, or exposure toradiation. Lighting devices which are utilized in such procedures arefrequently protected by metal or plastic handles that may be easilyremoved, sterilized, and thereafter reattached to the lighting device.These handles are necessarily fabricated from materials which canwithstand repeated exposure to the sterilizing environment. Recently,fiber optic devices, frequently referred to as light-pipes have beenprovided for use in surgical operations. These structures permit thebending of the fiber bundle at will, and these structures permit thesurgeon to arrange the output of the light-pipe to direct lightimmediately into the operative field. One such surgical lamp structureis disclosed in the patent application entitled FIBER OPTICS FORSURGICAL LAMP referred to hereinabove.

Those illuminating structures presently in widespread use normallyposition the light source a distance from the open wound and, therefore,when individuals attending the patient place their heads or hands in thearea of the wound, the light may beblocked. This elimination of lightbecomes particularly critical when the surgical team is working in deepwounds or in a body cavity, such as the thorax where the entrance sizeis particularly limited. Since light from a proximate source is easilyand heavily shadowed, access, inspection, or any other activity close tothe wound area becomes extremely difiicult for those individualsattending the patient. Light is easily blocked, and those in attendancemay, in rely instances, ry upon only reflected light, including lightwhich is reflected from the sides of the wound. Such lighting problemsare also encountered when remote sources of light, including ceilinglights and portable spotlights are being used.

In order to permit application of the fiber optic illuminator structureto a variety of surgical procedures, sterility of the illuminatorstructure in proximity to any wound must be assured. The fiber opticbundle is preferably rendered sterile by enclosing or covering thatportion of the bundle which is adjacent the patient. At the presenttime,-such sterility is achieved by utilizing a detachable metal sleeve,with the sleeve covering the fiber bundle, and being positionedimmediately above the wound, with the metal sleeve being subjected tosterilizing procedures before each use. As an alternative, the bundle offibers may be subjected to sterilizing operations. Unfortunately,however, light fibers are not fabricated from materials sufficientlydurable to readily withstand repeated exposure to sterilizingenvironments.

According to present techniques, the sterilization of the detachablemetal sleeve, or of the fiber bundle is normally accomplished byunskilled personnel. The routine required for removing and replacing thefiber bundle, or the metal sleeve is also normally conducted byrelatively unskilled personnel, and contamination may occur during thereplacing of the structures. Mod- I est amounts of foreign material,such as foreign protein or blood or drugs may provide a potentiallylethal anaphylactic reaction during the subsequent exposure to a patientwho may be allergic to such materials. Such an allergic reaction mayoccur even though normal sterilization operations had been employed.

According to the present invention, a flexible, disposable tubularsheath is provided which may be mass produced, sterilized, and packagedprior to use, which sheath may be secured to a surgical illuminatingstructure prior to use. The sheath and lens structures of the presentinvention are designed to cover that portion of the surgicalilluminating apparatus which comprises the bundleof fiber optics, alongwith the bundle lens disposed at the distal end. As such, the structurecovers that portion of the fiber bundle which must be sterilized for useduring surgical procedures.

At the termination of each surgical procedure, the sheath apparatus ofthe present invention is removed from the illuminating apparatus anddiscarded with the structure being then ready .for application of a newsheath apparatus for subsequent cases. Since each sheath is sterile whenapplied, the danger of crosscontamination from previous exposures is, ofcourse, substantially eliminated.

In order to provide for ease of placement of the tubular sheath onto thefiber'bundle, a pair of slots are formed along the rear open portion ofthe tube, with one of the slots being substantially longer than theother. Such an arrangement provides for the formation of a pair ofasymmetrical grasping cars which, by virtue of their configuration,enable simple and straightforterminal lens. The tip end of the sheathis, of course,

closed and sealed, with the tip end being designed to minimize anyinterference with the light pattern emitting from the lens. The lensportion of the structure is arranged to be disposed in series with thelighttransmitting lens of the surgical illuminator. As such, the lensportion may be provided with specific contours so as to form, forexample, a Fresnel-type lens or the like. Alternately, the end surfacemay be textured so as to disperse the wide output about a substantiallywide angle.

SUMMARY OF THE INVENTION The present invention makes it possible toutilize a convenient light source which is encased or enclosed within asterile sheath environment. The sterile sheath structures are fabricatedfrom materials which may be relatively quickly sterilized and packaged,and which in use, can tolerate exposure to mechanical contact with asubstantial number of the devices employed during surgical operations.In addition, the sterile sheath structures are formed so as topermit'easy application onto a bundle o f fiber optics, with the sheathstructure providin g a meah stoenhance the light output of the lenswhich is normally disposed at the distal end of the fiber bundle. Thesheath structure is fabricated from readily disposable materials.

Therefore. it is a primary object of the present invention to provide animproved sterile sheath structure which may be applied to the surfaceofa surgical illuminating apparatus employing a bundle of opticalfibers.

i a bundle of optical fibers which are utilized to transmit light from asource to a remote point, with the sheath structure being easilyarranged over the surface of the bundle and readily removed therefrom,and providing a closed lens element or cap structure.

It is yet a further object of the present invention to provide a sterilesheath and lens element for covering an elongated bundle of opticalfibers utilized to transmit light from a remote source to a distal tipend lens, with the sheath structure and its lens element being durableso as to tolerate exposure to casual contact with surgical instruments.

Other and further objects of the present invention will become apparentto those skilled in the art upon a study of the following specification,appended claims, and accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a front elevational view ofthe optical por tion of a sy rgical lamp, and illustrating a lightsource with portions of the supporting structure removed, and with the buridle of fiber optics extending therefrom being covered bya sh eath"and lens element structure prepared in accordance with the presentinvention;

FIG. 2 is a sectional view taken along and through the diameter of thebundle of fiber optics disposed at the distal tip end ofthe bundle, thisview being taken along the line and in the direction ofthe arrows 22 ofFIG. 1;

FIG. 3 is a detail perspective view of the open end portion only of thesheath structure as shown in FIG.

1, it being apparent that FIGS. 2, 3, and 4 are each taken on a slightlyenlarged scale; and

FIG. 4 is a sectional view similar to FIG. 2 and showing a modified formof lens element.

DESCRIPTION OF THE PREFERRED EMBODIMENT With particular attention beingdirected to FIG. I of the drawing, it will be observed that the sheathstructure generally designated 10 is illustrated as it is applied to thefiber optic bundle 12 extending from the illuminating lamp sourcegenerally designated 13. The lamp source 13 includes a housing 14 whichconfines the light source per se, with the housing 14 being supported bysuitable supports 15l5 coupled to trunions 16-16. Housing 14 is furtherprovided with a ferrule means I7 which adapt and retain the bundle 12 inworking relationship with the light source.

It will be appreciated that the details of construction of theilluminating device are not critical to the sheath apparatus of thepresent invention, however, for purposes of comprehension of theinvention, one typical surgical illuminator device utilizing fiberoptics is illustrated in application Ser. No. 65,222, referred tohereinabove.

With continued attention being directed to FIG. 1, and with attentionalso being directed to FIG. 2, it will be observed that the tip endportion 20 of the sheath structure is in the form ofa generally rigidlens element sealed to the sheath along a continuous sealing line, suchas is shown at 21 in FIG. 2. This seal is preferably formed by adhesivebonding or other conventional plastic sealing techniques.

The lens element 20 of the sheath apparatus is preferably formed with agenerally hemispherical outer exposed tip end and a generallycylindrical shank portion. The outer diameter of the shank portion ispreferably less than the inner diameter of the surrounding sheath, thusenhancing the fit and providing for a more secure and rigid structurewhich is free from contamination. Such a structure may tolerate fluidswhich are susceptible to capillary attraction between the sheathstructure and these fluids which may occasionally come into contact withthe sheath structure. It will be appreciated that blood would be likelyto come in contact with the sheath, and capillary attraction between theblood and the sheath would, of course, be undesirable. The bond betweenthe cylindrical shank portion of the lens element and the sheath is, ofcourse, continuous about and adjacent the outer edge of the sheath.

The lens element of the present invention may be fabricated from anysuitable material such as, for example, vinyl plastic, polystyrene, orthe like. Each of these materials are, of course, commercially availablein the form required.

With attention now being directed to FIG. 3 of the drawing, it will beobserved that a pair of grasping ears are provided at the end of thetubular sheath portion 22, as at 23 and 24. These grasping ears areprovided along either side of a pair of slots formed in the tubularstructure 22, as at 25 and 26. It will be observed that these slots areof substantially different axial lengths, thereby providing graspingears which are asymmetrical in form.

As materials of construction, it is preferred that the sheath structurebe fabricated from a durable film of flexible plastic material, such as,for example, vinyl plastic tubing or the like. With a normal vinyltubing, a wall thickness of between 3 and 6 mils is normally desired forproviding the durability, rigidity, and transparency required, withoutadversely affecting the light output. Wall thicknesses in this range donot interfere with the mechanical handling of the fiber optic bundle.

As has been indicated, the slotted area 25 is substantially shorter inlength than the slotted area 26. Normally, for most materials, the slot25, which is the shorter of the two, will have a length substantiallyequal to the sheath diameter, while the longer slot will have a lengthequal to substantially two sheath diameters.

This degree of asymmetry provides a structure which is easily pulledonto the surface of the tubular bundle of fibers, which tubular bundleis, itself, normally confined within a stationary plastic sheath.

It will be appreciated that a variety of flexible thermoplastic orthermosetting films may be employed as the material to form the tubularstructure. In addition to the vinyl tubing, other flexible tubingfabricated from materials such as polyolefins, including polyethylene orpolypropylene, along with a film such as tubular polyethyleneterephthalate may be employed. Such materials are, of course,commercially available.

In a modified embodiment, a portion of the lens tip is rendered opaque,with a probe element arranged in extension of the tip end. Such anextension may function as a mini-probe at the tip end of the structure,if desired.

What is claimed is:

1. In a surgical illuminating lamp structure having an elongatedenclosed light-transmitting shaft with a closed light-transmitting lensmeans disposed at the tip end of the light-transmitting shaft to form acomplete enclosure, a sheath means for enclosing said lamp structure,said sheath means comprising:

a. an elongated tubular sheath fabricated of flexible film and having alight-transmitting lens element secured to one end thereof to form aclosed tip end and an opening at the other end thereof, said elongatedtubular sheath having an inner diameter which exceeds the outer diameterof said lighttransmitting shaft so as to be received thereover, saidsheath having a substantial length to cover a substantial portion ofsaid light-transmitting shaft during surgical procedures;

b. said sheath lens being arranged to be disposed in series with thelight-transmitting lens of said surgical illuminating lamp structure.

2. The sheath means as defined in claim 1 being particularlycharacterized in that said lens element has a general hemisphericalouter exposed tip end and a generally cylindrical shank portion.

3. The sheath means as defined in claim 2 being particularlycharacterized in that the outer diameter of said shank portion isgenerally less than the inner diameter of said tubular sheath.

4. The sheath means as defined in claim 1 being particularlycharacterized in that said light transparent lens element is secured tosaid elongated tubular sheath by a bond extending continuously betweenthe outer surface of said cylindrical shank portion and the innersurface of said cylindrical shank portion and the inner surface of saidsheath, with said bond being disposed adjacent the outer edge of saidsheath.

5. The sheath means as defined in claim 1 being particularlycharacterized in that said elongated tubular sheath has a pair ofgenerally axially extending slots formed adjacent the open end thereofto form a pair of grasping ears, the first of said axially extendingslots having a length in substantial excess of the other to form a pairof asymmetrical grasping ears.

6. The sheath means as defined in claim 1 being particularlycharacterized in that said light-transmitting lens element isprovidedwith a plurality of lenticular elements on the surface thereof totransmit light therethrough asymmetrically.

7. The sheath means as defined in claim 1 being particularlycharacterized in that said generally hemispherical outer exposed tip endof said lens element is partially opaque.

UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No.3,809,072 Dated y 1974 lnventor(s) Robert A. Ersek, et al It iscertified that error appears in the above-identified patent and thatsaid Letters Patent are hereby corrected as shown below:

Column 2, line 8, "inrely instances, ry" should read in certaininstances, rely Signed and sealed this 10th day of September 1974.

(SEAL) Attest:

MCCOY M. GIBSON, JR. C. MARSHALL DANN Attesting Officer Commissioner ofPatents FC-?M r c-1050 (10-69) USCOMM-DC 60376-P69 U.S. GOVERNMENTPRINTING OFFICE: I969 O-"366-334 UNITED STATES PATENT ()FEICECERTIFICATE OF CORRECTION Patent NO. 3 809 ,072 Dated y ,7 1 74Tnventor(s) Robert A. Ersek, et al It is certified that error appearsthe above-identified patent I and that said Letters Patent are herebycorrected as shown below:

Column 2, line 8, -"in r ely instances, ry" s houl c1 read in certaininstances, rely Signed and sealed this 10th day of September 51974(SEAL) Attest: v

MCCOY M. GIBSON, JR. (3, MARSHA LL DANN v t Attesting Officer 1 Y 1Commissiqner of Patents U.S. GOVERNMENT PRINTING OFFICE 119.9 0-366-334"

1. In a surgical illuminating lamp structure having an elongatedenclosed light-transmitting shaft with a closed lighttransmitting lensmeans disposed at the tip end of the lighttransmitting shaft to form acomplete enclosure, a sheath means for enclosing said lamp structure,said sheath means comprising: a. an elongated tubular sheath fabricatedof flexible film and having a light-transmitting lens element secured toone end thereof to form a closed tip end and an opening at the other endthereof, said elongated tubular sheath having an inner diameter whichexceeds the outer diameter of said lighttransmitting shaft so as to bereceived thereover, said sheath having a substantial length to cover asubstantial portion of said light-transmitting shaft during surgicalprocedures; b. said sheath lens being arranged to be disposed in serieswith the light-transmitting lens of said surgical illuminating lampstructure.
 2. The sheath means as defined in claim 1 being particularlycharacterized in that said lens element has a general hemisphericalouter exposed tip end and a generally cylindrical shank portion.
 3. Thesheath means as defined in claim 2 being particularly characterized inthat the outer diameter of said shank portion is generally less than theinner diameter of said tubular sheath.
 4. The sheath means as defined inclaim 1 being particularly characterized in that said light transparentlens element is secured to said elongated tubular sheath by a bondextending continuously between the outer surface of said cylindricalshank portion and the inner surface of said cylindrical shank portionand the inner surface of said sheath, with said bond being disposedadjacent the outer edge of said sheath.
 5. The sheath means as definedin claim 1 being particularly characterized in that said elongatedtubular sheath has a pair of generally axially extending slots formedadjacent the open end thereof to form a pair of grasping ears, the firstof said axially extending slots having a length in substantial excess ofthe other to form a pair of asymmetrical grasping ears.
 6. The sheathmeans as defined in claim 1 being particularly characterized in thatsaid light-transmitting lens element is provided with a plurality oflenticular elements on the surface thereof to transmit lighttherethrough asymmetrically.
 7. The sheath means as defined in claim 1being particularly characterized in that said generally hemisphericalouter exposed tip end of said lens element is partially opaque.